Thursday, August 30, 2012

ISO9000 and the Quality Management Principles

I was reviewing “The ISO9000 Essentials – 4th Edition” as I prepare to update my notes for our on-line course and the new Resident Training program, and I came across an interesting table that I had overlooked before, entitled “Quality Management Principles”.  I am not sure of the history of the table, but the information is readily available through a brochure that is available on the ISO website (

As I reflected upon the list, I came to the conclusion that regardless if you seek 3rd party recognition through an accreditation program or a certification program, or if you plan to implement Quality without benefit of an external assessment, these principles are excellent and should be a part of every organization’s mission and vision.

Here is the list:
1. Customer focus
2. Leadership
3. Involvement of people
4. Process approach
5. System approach to management
6. Continual improvement
7. Factual approach to decision making
8. Mutually beneficial supplier relationships.

Most of these are self explanatory, even in the context of the medical laboratory.  If the laboratory does not keep patients and clinicians front of mind, then they do not deserve to stay in operation.  If leaders don’t take care of the present, and at the same time keep their eye on progress and future trends, then their organization will soon become obsolete and vulnerable.   If leaders don’t create opportunities for staff to become engaged, their staff can, and will and should leave.  Management should not need a certification body or an accreditation body to remind them of these realities. Incoming complaints and discontented and leaving staff are loud signals that the public sector hospital leadership or the private sector CEO can not and will not ignore.  

Continual improvement, in its traditional sense, should be a given.  If you don’t learn from errors and accidents then you are likely to repeat them over and over.  It should be inherently obvious that when the bad thing occurs, someone should think “well let’s make sure that doesn’t happen again”!  Any management group that does not understand that has lost before it starts.  This doesn’t have to be a formal process, although a formal process helps because it will likely pick up the conditions for error earlier and with less potential damage.  

With respect to making decisions based on actual information, I am reminded of the recent Dilbert cartoon from the other day where the manager says “From now on, I’m going to rely on my intuition rather than on market research”, to which Dilbert replies “If guessing can bring your success rate up to 50 percent, I am all for it.”  Not every decision needs a full scale investigation and report, but on the other hand, who needs a management team when flipping a coin works just as well.  Again this should be inherent management knowledge, and should not need an assessor’s view.

Systems approach and process improvement are another matter.  Maintaining a structured process in laboratory testing makes sense because it increases consistency, reduces the risk of error, and in both the long and short run saves time, effort, energy and money.  But by and large, most of the downside can be hidden from view for a long time.  Budgets can appear to be in control, and hospital executives tend to become aware of injuries and accidents and excessive sick time only when they become union issues or when the reports from the watchful eye of external assessment comes to the fore.  Mission and vision statements and Quality policies and adherence to programs of internal audits can all too often slip by the wayside unless management is diligent.  The watchful eye of a 3rd party assessor increases the likelihood of attention to detail.

Of the eight principles, probably the one on supplier relations is the weakest.  This is not because of less regard for suppliers (we include suppliers within the group of Quality Partners [ see]
) but rather because it is too specific to a principle.  There are all sorts of groups with whom the laboratory should be seeking out mutually beneficial relationships, including government, administration, clinicians, patients and education providers.  This principle probably needs restating using broader terminology and concepts.

My bottom line: The list of Quality Management Principles is essential information at every level.  I recommend that you visit and look under ISO9000 Quality Management and find the Principles brochure.  You will be glad you did.

PS: ISO Technical Committee 176, the group responsible for ISO9000 has started the process of revision for the principles.  We will follow (and participate) with interest.


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